Stem Cell Treatment for Myocardial Disease Trial Largest of its Kind in U.S.

April 9, 2009 - A successful randomized, double-blinded, placebo-controlled phase 2 clinical trial using an intramyocardial injection of a patient’s own CD34 stem cells as treatment for refractory angina has been completed, and included 22 centers across the U.S.

The phase 2 study, designed to test the ability of a patient’s own stem cells (CD34 cells) to improve blood flow to the heart, could show the ability to improve heart function and reduce the possibility of events such as hospitalizations and heart failure in patients with refractory angina. A total of 167 patients were randomized and completed the injection procedure, and 162 patients completed the six-month evaluation.

“The results from this study provide the first significant evidence that a patient’s own stem cells can actually be used as a treatment for their heart disease,” said Douglas Losordo, M.D., lead author from Northwestern University, Chicago. “This study provides some hope for those patients with currently untreatable angina to be more active with less pain.”

Phase 2 of the study provides information about appropriate endpoints regarding suitability and sample size of this therapy for a phase 3 efficacy study, the final study that will ultimately determine if the treatment works.

A key slide from Elnabawi's presentation, showing cardiac CT plaque evaluations, showing the impact of psoriasis medication on coronary plaques at baseline and one year of treatment. It shows a reversal of vulnerable plaque development.